A normal mitral heart valve, as viewed from the left atrium heart chamber, includes anterior and posterior mitral valve leaflets and the mitral valve annulus (FIG. 1A). The mitral annulus is the attachment point of the valve to the heart muscle and is composed of fibrous tissue. When the mitral heart valve develops leakage, clinically termed “mitral regurgitation” (FIG. 1B), it is associated with morbidity and mortality from congestive heart failure. Nearly all successful open-heart surgical methods to correct mitral valve regurgitation involve mitral valve annuloplasty, which involves reduction of the mitral valve annulus dimension or remodeling of the mitral valve annular shape. Surgical approaches to the mitral valve are invasive and carry significant risk, especially in sicker patients, and mitral annuloplasty can be difficult during conventional or even minimally invasive open-heart surgery, especially if the left atrium heart chamber is small in diameter.
A catheter-based approach to mitral valve annuloplasty would avoid surgical risk, but no catheter-based methods or devices for mitral valve annuloplasty have achieved safe, effective, durable, and reproducible correction of mitral regurgitation in tested clinical use. Previous methods with catheter-based devices for mitral valve annuloplasty have involved access to the mitral annulus through the left atrium, or through the left ventricular cavity adjacent to the chordae, or through the coronary sinus with juxtaposition to the mitral annulus. Previous methods which involve a retained foreign body in a heart chamber with a low-velocity of blood flow, such as the coronary sinus, the left atrium, or the inflow aspect of the left ventricle, may require life-long anticoagulation with its inherent complications.